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Starlix

Last reviewed on RxList: 4/11/2017
Starlix Side Effects Center

Last reviewed on RxList 04/11/2017

Starlix (nateglinide) is an oral diabetes medicine used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with Starlix if needed. Starlix is available in generic form. Common side effects of Starlix include:

  • weight gain,
  • runny or stuffy nose,
  • sneezing,
  • cough,
  • cold or flu symptoms,
  • diarrhea,
  • nausea,
  • back pain,
  • dizziness, or
  • joint pain or stiffness.

Starlix can cause low blood sugar (hypoglycemia). Tell your doctor if you have symptoms of low blood sugar such as:

  • chills,
  • cold sweat,
  • dizziness,
  • drowsiness,
  • shaking,
  • fast heartbeat,
  • weakness,
  • headache,
  • fainting,
  • tingling of the hands or feet, or
  • hunger.
Tell your doctor if you have serious side effects of Starlix including:

The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals. Hyperglycemia (high blood sugar) may result if you take Starlix with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Starlix with drugs that lower blood sugar, such as: non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. Tell your doctor all medications you use. During pregnancy, Starlix should be used only when prescribed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor to manage blood sugar while pregnant. Your doctor may change diabetes treatment during your pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Starlix (nateglinide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Starlix Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • runny or stuffy nose, sneezing, cough, cold or flu symptoms;
  • diarrhea, nausea;
  • back pain;
  • dizziness; or
  • joint pain or stiffness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Starlix (Nateglinide)

Starlix Professional Information

SIDE EFFECTS

The following serious adverse reaction is also described elsewhere in the labeling:

Hypoglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with STARLIX. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with STARLIX.

Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in STARLIX-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials

  Placebo
N=458
STARLIX
N=1441
Preferred Term
Upper Respiratory Infection 8.1 10.5
Back Pain 3.7 4.0
Flu Symptoms 2.6 3.6
Dizziness 2.2 3.6
Arthropathy 2.2 3.3
Diarrhea 3.1 3.2
Accidental Trauma 1.7 2.9
Bronchitis 2.6 2.7
Coughing 2.2 2.4

Hypoglycemia

Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with STARLIX. Non-severe hypoglycemia occurred in 2.4 % of STARLIX treated patients and 0.4 % of placebo treated patients [see WARNINGS AND PRECAUTIONS].

Weight Gain

Patients treated with STARLIX had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with STARLIX 60 mg (3 times daily) and STARLIX 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively.

Laboratory Test

Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with STARLIX alone, STARLIX in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of STARLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Hypersensitivity reactions: Rash, itching, and urticaria
  • Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

Read the entire FDA prescribing information for Starlix (Nateglinide)

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